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USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies
Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...
Sharan Murugan
Apr 4, 20242 min read
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USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know
Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA)Â released guidance "Charging for Investigational...
Sharan Murugan
Feb 17, 20241 min read
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USFDA Proposal: IND Annual Reports for More Comprehensive, Consistent with International Regulations
Earlier today (08-December-2022), the US Food and Drug Administration proposed a new annual reporting requirement for investigational new...
Sharan Murugan
Dec 8, 20221 min read
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USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA
Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...
Sharan Murugan
Nov 1, 20221 min read
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USFDA Guidance: Charging for Investigational Drugs Under an IND: Questions and Answers
This draft guidance is released today for Public comments and when finalized, this guidance will replace Charging for Investigational...
Sharan Murugan
Aug 22, 20221 min read
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FDA's Bioavailability Guidance for NDAs or INDs- General consideration
The US Food and Drug Administration (FDA) has published a final guidance regarding bioavailability data that drug sponsors should include...
Sharan Murugan
Apr 17, 20222 min read
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